Spinal Simplicity has launched a new generation of Minuteman G3 fusion device, featuring a US Food and Drug Administration (FDA)-cleared coating of hydroxyapatite.
“Hydroxyapatite has been used in orthopaedic procedures for the last 30 years because of its successful track record,” says Todd Moseley, chief executive officer and co-founder, Spinal Simplicity.
“For companies to try to accomplish what we are doing retrospectively, they would have to seek new clearances from the FDA. By switching to sterile pack processing—they would have to start over with new inventory, requiring excessive time and money,” says Jonathan Hess, vice president of Business Development. According to a company release, this implant is provided sterile-packed.